All documents shown here are included in the seminar for instant download

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for
instant download. All reference material as listed below and more is
available on a special seminar website. The website is regularly
updated with most recent information. In case there are questions
related to the topic, they can be submitted through a web form and
will be answered by the speaker. For ordering info
click here.

On-line Audio Seminar 118

Validation and Use of Excel® Spreadsheets
in GLP/GMP and Part 11 Environments

Recorded

Excel® Applications are widely used in laboratories, offices and manufacturing
e.g., for data capture, data manipulation and report generation. They are
considered software and should be validated when used in regulated environment.
For example the new FDA Guidance on Using Computers in Clinical Trials states
for spreadsheet applications: FDA suggests that the sponsor or contract research
organization perform functional testing (e.g., by use of test data sets) and
research known software limitations, problems, and defect corrections.

Most Excel® applications are non-trivial, may be widely shared and will contain
significant investments in time and intellectual effort. Frequently users of
such programs are also programmers and are afraid to go through the big efforts
usually associated with software and computer systems validation. Their main job
is not software development or code inspection.

Questions are:

What is it we should validate?

I have been using these spreadsheets since years, I know
that they work, why should I start to validate?

How to overcome Excel® limitations for part 11?

What to do and document for risk assessment?

How does FDA's new approach for part 11 compliance impact
Excel?

Should we test standard Excel® functions?

Should we validate ad 'hoc' or 'one time use' Excel®
spreadsheets?

What and how much should we document?

When can we delete e-records and when should we keep them?

How does the FDA validate spreadsheets for their own
regulations?

How to ensure spreadsheet integrity for part 11 compliance?

How to apply risk based validation to Excel spreadsheets?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. Dennis
Cantellops from the US FDA will answer questions. After the seminar,
an extensive list of reference material like SOPs, templates and
examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

FDA and EU requirements for spreadsheet validation - What do
inspectors ask and what documents should be available.

How to design spreadsheets for part 11/GxP compliance

Validation and Part 11 compliance in FDA laboratories: The
FDA information bulletin:

Validation during design, development, installation and
on-going use

When, what and how much to test?

How to handle standard Excel functions?

How to ensure and validate spreadsheet integrity for GxP and
part 11?

How to apply risk based validation to spreadsheet
applications

Validation of 'ad hoc' spreadsheet applications.

How to document planning, specifications, installation,
testing and changes

Examples from manufacturing, laboratories and offices

And for easy and instant implementation:
download 10+ documents from special seminar website

FDA Laboratory Information Bulletin I: Spreadsheet Design
and Validation for the Multi-User Application for the Chemistry
Laboratory (not available on FDA's public website).

FDA Laboratory Information Bulletin II: Spreadsheet Design
and Validation for the Single-User Application for the Chemistry
Laboratory (not available on FDA's public website).

SOPs:
- Validation of spreadsheets and other computer applications,
- Development and use of spreadsheets in regulated environments
- Change control of software and computer systems

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.